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Denis Jacob, presidente do Comitê de Ética da Abimed, é entrevistado pela Scrip Regulatory Affairs
Publicado em 31/05/2015 • Notícias • Português
Brazil presses on with anti-corruption drive
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01 June 2015
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Neena Brizmohun
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Pharmaceutical and medical technology companies operating in Brazil can expect to see the implementation of additional measures relating to anti-bribery rules in the country.
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Following the Clean Companies Act, which came into effect in January 20141, “”there is still some discussion related to improvements on the application of the law””, according to Denis Jacob, compliance officer Americas and Europe at BD and chairman of the Brazil Compliance Work Group at US medical device industry association AdvaMed. The discussion concern matters “”such as the use of leniency agreements and the consistency of the enforcement within several government agencies””, Mr Jacob told Scrip Regulatory Affairs, adding that “”those matters should be adjusted along with new cases and settlements””.
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According to law firm Covington & Burling2, a decree that came into effect in Brazil earlier this year to flesh out aspects of the Clean Companies Act is “only one of a series of anti-bribery measures expected to be implemented in Brazil to address the perceived problem of corruption”3. Decree No 8,420, which became effective on 19 March, “notes that additional regulations and guidelines relating to the governance and assessment of compliance programs shall be issued by the Comptroller-General of the Union,” the Covington & Burling lawyers said.
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The Clean Companies Act for the first time subjected medtech, pharma and all other companies operating in the country to civil and administrative sanctions for bribing either Brazilian or foreign public officials. The act also “contains potentially powerful incentives for voluntary disclosure”, the lawyers noted.
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According to Mr Jacob, “”decree 8420 was the milestone that the compliance community in Brazil was anxiously waiting [for] to regulate the application and interpretation of the Clean Company Act””. He described it as “”a fundamental instrument of the application and enforcement of Brazil´s Clean Company Act, as it establishes guidelines for a consistent interpretation of law as well to determine the assumptions to assess the effectiveness of Compliance Programs””. In addition, he noted, “”it contains a well-defined methodology for calculating fines, including additions and deductions resulting of a range of items””, including co-operation, self-disclosure, and the existence of an effective compliance program.
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For Covington & Burling, the most notable aspect of the decree is its emphasis on the implementation of effective compliance programs. The decree deals with “exactly how much the existence of a compliance program will mitigate any fine imposed” and it sets out aspects of a compliance program that will be weighed to determine its effectiveness.
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Mr Jacob remarked that the Clean Company Act and decree 8,420 are part of Brazil anti-corruption efforts aligned with several international initiatives, including the OECD (Organisation for Economic Co-operation and Development) and UN conventions, the US Foreign Corrupt Practices Act, and the UK Bribery Act. Companies should therefore “”assess their risk environment and implement effective procedures to prevent corruption and remediate cases of non-compliance””.
Fonte: Scrip Regulatory Affairs
